SWIFTWATER, Pa., Dec. 9, 2019 /PRNewswire/ -- Sanofi Pasteur, the
vaccines global business unit of Sanofi, has entered into an
agreement with the U.S. Department of Health and Human Services
(HHS) to increase the company's domestic pandemic influenza vaccine
production capabilities based in Swiftwater, Pennsylvania.
The contract is supported by federal funds from the Biomedical
Advance Research and Development Authority (BARDA), part of the
Office of the Assistant Secretary for Preparedness and Response at
HHS.
"We are pleased to be taking this critical next step in our
longstanding relationship with BARDA, which will enable us to
significantly enhance flu vaccine supply under pandemic influenza
scenarios," said David Loew,
Executive Vice President, Vaccines at Sanofi. "We are deeply
committed to advancing influenza vaccine technology and
manufacturing, and our public and private partnerships are an
important part of these ongoing efforts to help protect people from
influenza."
"The question is not if, but when the next influenza pandemic
will occur, carrying potentially devastating consequences for
public health and the U.S. economy," said BARDA Director
Rick Bright, Ph.D. "As the recent
presidential executive order on pandemic preparedness emphasized,
technology to produce effective vaccines quickly and safely in
the United States can improve
access, protect more people sooner and, ultimately, strengthen
national and global health security. Public-private partnerships,
such as this one with Sanofi Pasteur, are essential in moving such
technology forward."
The contract will support the clinical development and
manufacturing of an adjuvanted recombinant pandemic vaccine to help
enhance U.S. and global pandemic preparedness. This
investigational pandemic vaccine will utilize the same recombinant
technology as Sanofi's Flublok® Quadrivalent (influenza
vaccine). In addition, the contract will expand the site's role as
a center of excellence for pandemic preparedness by adding both
recombinant and adjuvant manufacturing alongside current egg-based
manufacturing.
Flublok Quadrivalent is indicated for adults 18 years of age and
older and proven in a randomized controlled trial to help prevent
30 to 43 percent more cases of laboratory-confirmed influenza in
people 50 years of age and older compared to a standard-dose
quadrivalent inactivated influenza vaccine.i Flublok
Quadrivalent is the only recombinant protein-based influenza
vaccine approved by the U.S. Food and Drug Administration (FDA),
uniquely providing an exact genetic match of hemagglutinin (HA)
from each recommended vaccine virus. HA is the protein identified
as key to stimulating immunity to influenza.
What is Flublok® Quadrivalent (Influenza
Vaccine)?
Flublok Quadrivalent is a vaccine indicated for
the prevention of influenza disease caused by influenza A and B
strains contained in the vaccine. Flublok Quadrivalent is given to
people 18 years of age and older.
IMPORTANT SAFETY INFORMATION FOR FLUBLOK®
QUADRIVALENT (INFLUENZA VACCINE)
Flublok Quadrivalent should
not be given to anyone who has had a severe allergic reaction to
any component of the vaccine or after previous dose of the
vaccine.
Tell your health care provider if you have ever had
Guillain-Barré syndrome (severe muscle weakness) after a previous
influenza vaccination.
If Flublok Quadrivalent is given to people with a compromised
immune system, including those receiving therapies that suppress
the immune system, the immune response may be lower than
expected.
Vaccination with Flublok Quadrivalent may not protect all people
who receive the vaccine.
For Flublok Quadrivalent, in adults 18 through 49 years of age, the
most common side effects were tenderness, and/or pain where you got
the shot; headache, tiredness, muscle aches, and joint pain. In
adults 50 years of age and older, the most common side effects were
tenderness, and/or pain where you got the shot; headache, and
tiredness. Other side effects may occur.
Before administration, please see the full Prescribing
Information for Flublok Quadrivalent.
About Sanofi
Sanofi is dedicated to supporting people through their health
challenges. We are a global biopharmaceutical company focused on
human health. We help prevent illness with vaccines, provide
innovative treatments to fight pain, and ease suffering. We stand
by the few who suffer from rare diseases and the millions with
long-term chronic conditions.
With more than 100,000 people in 100 countries, Sanofi is
transforming scientific innovation into healthcare solutions around
the globe.
Sanofi, Empowering Life
Media
Relations Contact Nicolas Kressmann Tel.: +1 732-532-5318 Nicolas.Kressmann@sanofi.com
|
Investor Relations
Contact George Grofik
Tel.: +33 (0)1 53 77 45 45
ir@sanofi.com
|
Sanofi Forward-Looking Statements
This press release contains forward-looking statements as
defined in the Private Securities Litigation Reform Act of 1995, as
amended. Forward-looking statements are statements that are not
historical facts. These statements include projections and
estimates regarding the marketing and other potential of the
product, or regarding potential future revenues from the product.
Forward-looking statements are generally identified by the words
"expects", "anticipates", "believes", "intends", "estimates",
"plans" and similar expressions. Although Sanofi's management
believes that the expectations reflected in such forward-looking
statements are reasonable, investors are cautioned that
forward-looking information and statements are subject to various
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of Sanofi, that could cause actual
results and developments to differ materially from those expressed
in, or implied or projected by, the forward-looking information and
statements. These risks and uncertainties include among other
things, unexpected regulatory actions or delays, or government
regulation generally, that could affect the availability or
commercial potential of the product, the absence of guarantee that
the product will be commercially successful, the uncertainties
inherent in research and development, including future clinical
data and analysis of existing clinical data relating to the
product, including post marketing, unexpected safety, quality or
manufacturing issues, competition in general, risks associated with
intellectual property and any related future litigation and the
ultimate outcome of such litigation, and volatile economic
conditions, as well as those risks discussed or identified in the
public filings with the SEC and the AMF made by Sanofi, including
those listed under "Risk Factors" and "Cautionary Statement
Regarding Forward-Looking Statements" in Sanofi's annual report on
Form 20-F for the year ended December 31,
2018. Other than as required by applicable law, Sanofi does
not undertake any obligation to update or revise any
forward-looking information or statements.
i Flublok Quadrivalent PI. [Prescribing
Information]. Swiftwater, PA:
Sanofi Pasteur Inc.
https://www.vaccineshoppe.com/image.cfm?doc_id=14672&image_type=product_pdf.
Source: Sanofi (EURONEXT: SAN) (NYSE: SNY)
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